Quality Assurance Associate - Eurofins CDMO Alphora Inc

The Quality Assurance Associate will play a key role in ensuring Eurofins CDMO Alphora Inc.s compliance with Current Good Manufacturing Practices (cGMP) to ensure the production of safe and efficacious pharmaceutical APIs on behalf of our clients and their patients. This is an excellent opportunity to obtain experience in a pharmaceutical manufacturing setting and to work on projects related to all phases of the pharmaceutical product life cycle. This role will be engaging and challenging for an individual that has a desire to learn and thrives in a highpaced environment with a variety of new projects and unique challenges to overcome.

KEY DUTIES AND RESPONSIBILITIES:

• Liaise with production quality control and analytical services staff
• Review quality control lab data for raw materials inprocess controls intermediates and APIs for accuracy completeness and compliance to CGMP or other applicable regulatory standards
• Review executed batch records and production cleaning study reports for accuracy completeness and compliance to established CGMP or other regulatory standards
• Release intermediate and API batches that satisfy quality requirements
• Review analytical data and protocols for standard qualification stability method qualification and method validation protocols for accuracy completeness and compliance to GLP or other regulatory standards
• Provide production support including equipment and line clearances
• Review and approve laboratory and batch summary reports
• Review and approve quality documents including but not limited to sampling analysis and labeling forms deviations/amendments (planned deviations) OOS/OOT/OOC investigations  logbooks cleaning records and temperature monitoring data
• Perform oversight of final product packaging operations
• Review and input on Standard Operating Procedures (SOPs) 
• Review and feedback on deviation assessments
• Conduct root cause investigations related to deviations out of specifications and out of calibrations and evaluate related impact assessments and proposed Corrective Actions/Preventive Actions
• Assist in the development and establishment of suitable Corrective Actions/Preventive Actions (CAPAs) based on investigation outcomes
• Review change controls and QC specifications on a limited basis
• Assist in preparation for internal customer and regulatory agency audits
• Contribute to QA department meetings by providing project status reports as well as identifying and leading continuous improvement activities
• Participate in opportunities to develop knowledge of CGMP and business operations
• Other duties as assigned by the Quality Assurance Manager

Qualifications :

The ideal candidate will have:

• BSc; specialization in chemistry is preferred
• 25 years of experience
• An understanding of (cGMP) manufacturing with prior QA and/or laboratory experience being a definite asset
• Proficiency in Microsoft Office (Word/Excel)
• Strong written and verbal skills are a priority
• A proficiency for multitasking
• Excellent interpersonal skills
• Good time management and project management skills
• A focus on attention to detail
• Be goalorientated and resultsdriven
• A desire to learn and for continuous development

Additional Information :

At Eurofins we offer excellent fulltime benefits including health & dental coverage life and disability insurance RRSP with 3% company match paid holidays paid time off.

Accommodation: Persons with disabilities who need accommodation in the application process or those needing job postings in an alternative format may email a request via the website at 

As a Eurofins employee you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins please explore our website at 

We thank all applicants within commuting distance of GTA Ontario for showing an interest in this position. Only those selected for an interview will be contacted.

This posting is supported by AI technology to assist in screening candidates and resumes.

NO AGENCIES CALLS OR EMAILS PLEASE

Remote Work :

No

Employment Type :

Fulltime